Patient safety in anatomic pathology: measuring discrepancy frequencies and causes.

CONTEXT

Anatomic pathology discrepancy frequencies have not been rigorously studied.

OBJECTIVE

To determine the frequency of anatomic pathology discrepancies and the causes of these discrepancies.

DESIGN

Participants in the College of American Pathologists Q-Probes program self-reported the number of anatomic pathology discrepancies in their laboratories by prospectively performing secondary review (post-sign-out) of 100 surgical pathology or cytology specimens. Reasons for the secondary review included conferences, external review, internal quality assurance policy, and physician request.

PARTICIPANTS

Seventy-four laboratories self-reported data.

MAIN OUTCOME MEASURES

Frequency of anatomic pathology discrepancy; type of discrepancy (ie, change in margin status, change in diagnosis, change in patient information, or typographic error); effect of discrepancy on patient outcome (ie, no harm, near miss, or harm); and clarity of report.

RESULTS

The mean and median laboratory discrepancy frequencies were 6.7% and 5.1%, respectively. Forty-eight percent of all discrepancies were due to a change within the same category of interpretation (eg, 1 tumor type was changed to another tumor type). Twenty-one percent of all discrepancies were due to a change across categories of interpretation (eg, a benign diagnosis was changed to a malignant diagnosis). Although the majority of discrepancies had no effect on patient care, 5.3% had a moderate or marked effect on patient care.Conclusions.-This study establishes a mean multi-institutional discrepancy frequency (related to secondary review) of 6.7%.